ACCOLADE™ and VISIONIST™ CRT-P Pacemakers
Brand(s)
Last updated
Summary
Product
ACCOLADE™ and VISIONIST™ CRT-P Pacemakers
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| ACCOLADE™ Pacemaker | More than 10 numbers, contact manufacturer. | L301 |
| ACCOLADE™ Pacemaker | More than 10 numbers, contact manufacturer. | L321 |
| ACCOLADE™ Pacemaker | More than 10 numbers, contact manufacturer. | L300 |
| ACCOLADE™ MRI Pacemaker | More than 10 numbers, contact manufacturer. | L310 |
| ACCOLADE™ MRI Pacemaker | More than 10 numbers, contact manufacturer. | L311 |
| ACCOLADE™ MRI Pacemaker | More than 10 numbers, contact manufacturer. | L331 |
| VISIONIST™ CRT-P | More than 10 numbers, contact manufacturer. | U225 |
| VISIONIST™ CRT-P | More than 10 numbers, contact manufacturer. | U226 |
| VISIONIST™ X4 Crt-P | More than 10 numbers, contact manufacturer. | U228 |
| ESSENTIO Pacemaker | More than 10 numbers, contact manufacturer. | L100 |
| ESSENTIO Pacemaker | More than 10 numbers, contact manufacturer. | L101 |
| ESSENTIO Pacemaker | More than 10 numbers, contact manufacturer. | L121 |
| ESSENTIO MRI Pacemaker | More than 10 numbers, contact manufacturer. | L110 |
| ESSENTIO MRI Pacemaker | More than 10 numbers, contact manufacturer. | L111 |
| ESSENTIO MRI Pacemaker | More than 10 numbers, contact manufacturer. | L131 |
| PROPONENT Pacemaker | More than 10 numbers, contact manufacturer. | L200 |
| PROPONENT Pacemaker | More than 10 numbers, contact manufacturer. | L201 |
| PROPONENT Pacemaker | More than 10 numbers, contact manufacturer. | L209 |
| PROPONENT Pacemaker | More than 10 numbers, contact manufacturer. | L221 |
| PROPONENT MRI Pacemaker | More than 10 numbers, contact manufacturer. | L210 |
| PROPONENT MRI Pacemaker | More than 10 numbers, contact manufacturer. | L211 |
| PROPONENT MRI Pacemaker | More than 10 numbers, contact manufacturer. | L231 |
| ALTRUA 2 Pacemaker | More than 10 numbers, contact manufacturer. | S701 |
| ALTRUA 2 Pacemaker | More than 10 numbers, contact manufacturer. | S702 |
| ALTRUA 2 Pacemaker | More than 10 numbers, contact manufacturer. | S722 |
| VALITUDE CRT-P | More than 10 numbers, contact manufacturer. | U125 |
| VALITUDE X4 Crt-P | More than 10 numbers, contact manufacturer. | U128 |
Issue
Boston Scientific is initiating an advisory to provide information about a subset of pacemakers from the ACCOLADE™ family and VISIONIST™ CRT-Ps with an increased potential to initiate safety mode during telemetry or, in rare instances, other normal, higher-power operations due to latent, high battery impedance when the device reaches approximately four (4) years or less of remaining battery longevity.
Recall start date: December 12, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Boston Scientific Corporation
4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-76710
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